A Phase 1 first-in-human dose-escalation and dose-expansion study of BMF-219, an oral covalent menin inhibitor, in adult patients with AML, ALL (with KMT2A/ MLL1r, NPM1 mutations), DLBCL, MM, and CLL/SLL.
A Phase 1 first-in-human dose-escalation and dose-expansion study of BMF-219, an oral covalent menin inhibitor, in adult patients with acute myeloid leukemia (AML), acute lymphocytic leukemia (ALL) with mixed lineage leukemia 1-rearranged (KMT2A/ MLL1r), nucleophosmin 1 (NPM1), diffuse large b-cell lymphoma (DLBCL), multiple myeloma (MM), and chronic lymphocytic lymphoma (CLL)/ small lymphocytic lymphoma (SLL).
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
55
BMF-219 is orally administered in continuous 28 day cycles. Alternative BID dosage may be used.
University of California, Irvine
Irvine, California, United States
University of Southern California Norris Cancer Center
Los Angeles, California, United States
UCLA Department of Medicine
Los Angeles, California, United States
UC Davis Comprehensive Cancer Center
Sacramento, California, United States
Stanford Cancer Center
Stanford, California, United States
Determine Optimal Biologic Dose (OBD) and RP2D of BMF-219 monotherapy for (Cohorts 1, 2, 3 & 4)
Determine Optimal Biologic Dose (OBD) and recommended Phase 2 dose (RP2D) of BMF-219 monotherapy in subjects with refractory or relapsed (R/ R) acute leukemia (Cohort 1), diffuse large B-cell lymphoma (Cohort 2), multiple myeloma (Cohort 3), and chronic lymphocytic leukemia/ small lymphocytic lymphoma (Cohort 4).
Time frame: At the end of Cycle 1 (each Cycle is 28 Days in duration)
Evaluate the Safety treatment-emergent TEAEs and SAEs
Evaluate the Safety of BMF-219 as expressed by treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).
Time frame: 28 Days after last dose.
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Mayo Clinic
Jacksonville, Florida, United States
Mount Sinai Medical Center
Miami Beach, Florida, United States
Moffitt Cancer Center
Tampa, Florida, United States
Blood & Marrow Transplant Group of GA (Northside Hospital)
Atlanta, Georgia, United States
Northwestern University
Chicago, Illinois, United States
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